Polibond

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. September 5, 2023 Zirkonzahn Srl % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114 Re: K232691 Trade/Device Name: Polibond Regulation Number: 21 CFR 872.3760 Regulation Name: Denture relining, repairing, or rebasing resin Regulatory Class: Class II Product Code: EBI, ELM Dated: September 1, 2023 Received: September 1, 2023 # Dear Prithul Bom: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {1}------------------------------------------------ Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. # Michael E. Adjodha -S Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K232691 Device Name Polibond Indications for Use (Describe) Polibond is used to fix custom-fit prosthetic teeth in appropriately milled cavities of prosthetic bases. # Type of Use (Select one or both, as applicable) X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # K232691 510(k) Summary Zirkonzahn GmbH / Srl Polibond 8/24/2023 #### ADMINISTRATIVE INFORMATION | Manufacturer Name: | Zirkonzahn GmbH / Srl<br>An der Ahr 7<br>39030 Gais - Südtirol - Italy<br>Telephone: +39 0474 066660 | Consultant: | Aclivi, LLC<br>3250 Brackley Drive<br>Ann Arbor, Michigan 48105<br>Telephone: +1 810 360-9773 | |--------------------|------------------------------------------------------------------------------------------------------|-------------|-----------------------------------------------------------------------------------------------| | Official Contact: | Sorana Siclovan - Project Management<br>regulatory.affairs@zirkonzahn.com | | Chris Brown - Manager<br>acliviconsulting@gmail.com | #### DEVICE NAME AND CLASSIFICATION | Trade/Proprietary Name: | Polibond | |-------------------------|----------------------------------------------------------------------------------------------| | Device: | Resin, denture, relining, repairing, rebasing | | Regulation Number: | 21 CFR 872.3760 | | Regulation Name: | Denture relining, repairing, or rebasing resin | | Device Class: | Class II | | Product Code: | EBI | | Review Panel: | Dental | | Reviewing Branch: | Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1)<br>Dental Devices (DHT1B) | #### PREDICATE DEVICE INFORMATION The Subject device in this submission is substantially equivalent in indications, use and design principles to the following Predicate device. | 510(k) | Predicate Device Name | Company Name | |---------|-----------------------|------------------------------------| | K191926 | VITA VIONIC Bond® | VITA Zahnfabrik H. Rauter GmbH Co. | #### INDICATIONS FOR USE Polibond is used to fix custom-fit prosthetic teeth in appropriately milled cavities of prosthetic bases. #### DEVICE DESCRIPTION The Subject device is a single-component self-cure bonding agent intended for use with milled PMMA denture base resins and milled PMMA denture teeth. The Subject device is used by a dental professional (dentist or dental technician) in the fabrication or repair of removable dentures. Dentures fabricated using the Subject device are one-time use, prescription-only devices. Polibond is intended for bonding Zirkonzahn PMMA materials such as Abro® Basic Multistratum® and Denture Gingiva Basic Mono resins in the manufacturing of dental prostheses. Abro® Basic Mono and Abro® Basic Multistratum® are dentin colored and used for milling denture Gingiva Basic Mono is a material used for milling denture bases. {4}------------------------------------------------ ### EQUIVALENCE TO MARKETED DEVICE The Subject device is highly similar to the Predicate device with respect to Indications for Use and technological principles. The comparison tables below compare the Indications for Use and Technological Characteristics of the Subject, Predicate and Reference devices. #### Indications For Use | Device | Indications for Use Statement | |----------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------| | Subject Device<br>Polibond<br>Zirkonzahn GmbH / Srl | Polibond is used to fix custom-fit prosthetic teeth in appropriately milled cavities of prosthetic<br>bases. | | Predicate Device<br>VITA VIONIC® Bond® (K191926)<br>VITA Zahnfabrik H. Rauter GmbH Co. | VITA VIONIC® Bond is used to fix custom-fit prosthetic teeth in appropriately milled cavities of<br>prosthetic bases. | The Subject and Predicate Indications for Use Statement (IFUS) are highly similar, only differing in the specific device names. The slight differences in the wording of the device names within Indications for Use Statements does not change the intended use of the Subject and Predicate devices to fix custom-fit prosthetic teeth in appropriately milled cavities of prosthetic bases. #### Technological Characteristics | Parameter | Subject Device | Predicate Device | Comparison | |-----------------------------------|------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|------------| | | Polibond<br>Zirkonzahn GmbH / Srl | VITA VIONIC Bond® (K191926)<br>VITA Zanhnfabrik H. Rauter GmbH Co. | | | Reason for<br>Predicate/Reference | n/a | IFUS, Technological Characteristics, | n/a | | Product Code | EBI | EBI | Same | | Device | Resin, denture, relining, repairing, rebasing | Resin, denture, relining, repairing, rebasing | Same | | Regulation | 21 CFR 872.3760 | 21 CFR 872.3760 | Same | | Regulation Name | Denture relining, repairing, or rebasing resin | Denture relining, repairing, or rebasing resin | Same | | Classification | Class II | Class II | Same | | Intended Use | Fix custom-fit prosthetic teeth in appropriately<br>milled cavities of prosthetic bases. | Fix custom-fit prosthetic teeth in appropriately milled<br>cavities of prosthetic bases. | Same | | Technology | Self-cure bonding agent for acrylic resin | Self-cure bonding agent for acrylic resin | Same | | Biocompatible | Yes | Yes | Same | | OTC or Rx | Rx | Rx | Same | | Sterile | Non-sterile | Non-sterile | Same | | How Supplied | Single bottle - Liquid | Two bottles - Liquid and Liquid | Similar* | | Principle of Operation | Self-curing bonding agent when the liquid is<br>applied to acrylic resin. (Self-curing) | Cured by chemical polymerization reaction starting with<br>mixing the liquid and liquid component then applied to<br>acrylic resin. (Self-curing) | Similar | | Performance Testing | ISO 20795-1 | ISO 20795-1 | Same | | Biocompatibility<br>Testing | ISO 10993-1<br>ISO 10993-3<br>ISO 10993-5<br>ISO 10993-10 | ISO 10993-1<br>ISO 10993-3<br>ISO 10993-5<br>ISO 10993-10 | Same | *See discussion below {5}------------------------------------------------ # Product Code/Device/Regulation/Regulation/Intended Use/Technology/Biocompatible/ Rx/Sterility - The Subject and Predicate devices are the same. How Supplied - The Subject and Predicate devices are similar as they are both liquids supplied in bottles. The Subject device is delivered in a single bottle, the Predicate device is two liquids supplied in separate bottles. The Subject device does not require mixing of liquids to accomplish the self-curing bonding process. The Predicate device requires mixing of two different liquids to create a compound that will result in a self-curing bonding agent. The number of bottles and need to mix does not change the intended use of the device to Fix custom-fit prosthetic teeth in appropriately milled cavities of prosthetic bases. The Subject device has demonstrated suitability for intended use through material non-clinical performance testing. Principle of Operation - The Subject and Predicate devices are the same in that they are both self-curing agents when applied to acrylic resin. However, the Subject device creates a self-cure chemical bond with a single liquid applied between the custom fit prosthetic teeth and milled prosthetic base. The Predicate device requires mixing of two different liquids to create a compound that results in a self-curing bonding agent. The number of liquids and a requirement to mix liquids prior to application does not change the intended use of the devices. Differences in usage technique are mitigated through performance testing. The Subject device has demonstrated suitability for intended use through material non-clinical performance testing including comparative testing with the Predicate device. Performance Testing – The Subject and Predicate devices were tested by their respective sponsors to the same ISO 20795-1 material property standard, meeting the relevant requirements of the standard which could be applied to a liquid such as the Subject device. Additionally, comparative tensile strength testing was performed with the Subject and Predicate devices and demonstrated similar performance. Biocompatibility - The Subject and Predicate devices were tested to the same biological testing endpoints. Overall, the Technological Characteristics of the Subject and Predicate devices are the Same or Similar. Technological differences between the Subject and Predicate devices have been evaluated through non-clinical performance testing. The results of the tests performed show that Subject device meets the requirements mentioned in the applicable standards and confirm that the Subject device performs similarly to the Predicate device based on the requirements of the standards. ### CLINICAL AND ANIMAL TESTING No clinical or animal testing data is included in this submission. # NON-CLINICAL PERFORMANCE TESTING Physical property testing was performed on the Subject device to ISO 20795-1, Dentistry — Part 1: Denture base polymers. Results demonstrated the Subject device meets the property requirements of the referenced standards for the endpoints which could be applied to self-curing bonding agents for denture base polymers such as the Subject device. Comparative tensile strength testing was performed with the Subject and Predicate devices and demonstrated similar performance between the Subject and Predicate devices. Shelf-life testing was performed to support the shelf-life stated in device labeling. A biological evaluation was performed on the Subject device. An abbreviated chemical characterization was performed along with a Toxicological Risk Assessment. Biocompatibility testing was performed on the Subject device according to ISO 10993-1:2018 according to the standards listed in the Technological Characteristics comparison table above. An MRI safety assessment was performed on the Subject device to support MR Safety labeling as required by the FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment". {6}------------------------------------------------ Non-clinical performance testing of the Subject device met the acceptance criteria for each validation and test described above. This non-clinical performance testing demonstrates that the Subject device is suitable for intended use. ## CONCLUSION Overall, the Indications for Use statements for the Subject and Predicate devices are highly similar differing only in device name. Overall, the Technological Characteristics of the Subject device are the same or similar to the Predicate device with any differences mitigated through non-clinical performance testing. Overall, these similarities between the Subject and Predicate devices support a determination of substantial equivalence.